Cleared Traditional

K803134 - TOXOPLASMA GONDII SEROLOGICAL REAGENTS

K803134 is the FDA 510(k) clearance for TOXOPLASMA GONDII SEROLOGICAL REAGENTS by Microbiological Research Corp.. It is a Class 2 Microbiology device (product code GLZ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K803134 · Microbiological Research Corp. · Microbiology device
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Jan 1981
Decision
48d
Days
Class 2
Risk

K803134 is an FDA 510(k) clearance for the TOXOPLASMA GONDII SEROLOGICAL REAGENTS. Classified as Antigens, If, Toxoplasma Gondii (product code GLZ), Class II - Special Controls.

Submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1981 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microbiological Research Corp. devices

Submission Details

510(k) Number K803134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date January 29, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GLZ Antigens, If, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GLZ Antigens, If, Toxoplasma Gondii

Devices cleared under the same product code (GLZ) and FDA review panel - the closest regulatory comparables to K803134.
TOXOPLASMA IGM IFA TEST SYSTEM
K924882 · Zeus Scientific, Inc. · Mar 1993
TOXO IGM TEST
K880007 · Gull Laboratories, Inc. · Mar 1988
ANTI-TOXOPLASMA GONDII KIT
K842664 · Amico Lab, Inc. · Aug 1984
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571 · Zeus Scientific, Inc. · Sep 1979
QUANTAZYME TOXOPLASMA
K790360 · Bio-Rad · May 1979
TOXO TEST
K772243 · Gull Laboratories, Inc. · Dec 1977